Seeking Alpha • Aug 31
Vectoring Back In On Verrica Pharmaceuticals
Summary
Shares of dermatology disease concern Verrica Pharmaceuticals Inc. plunged 64% on May 25, 2022 after the company received its third CRL for its molluscum candidate, VP-102.
However, the two most recent CRLs have to do with a deficient contract manufacturer, forcing the company to engage another one to get VP-102 across the finish line.
With significant insider and beneficial owner buying on its dilutive June 2022 secondary offering, Verrica merited a deeper dive.
A full investment analysis and recommendation follow in the paragraphs below.
Sometimes I wonder whether the world is being run by smart people who are putting us on or by imbeciles who really mean it.”― Laurence J. Peter, The Peter Principle
Today, we look at a small cap name I have not put under the microscope in a year and a half. The company recently suffered a setback at the hands of the FDA, but one that might be able to be rectified. The stock has seen some recent insider buying within a secondary offering as well. An analysis follows below.
Seeking Alpha
Company Overview:
Verrica Pharmaceuticals Inc. (VRCA) is a West Chester, Pennsylvania-based clinical-stage drug concern focused on the development of therapeutics for the treatment of dermatological diseases. It has two assets undergoing evaluation for four indications and another one in the preclinic. The company also has the dubious distinction of having received three complete response letters ((CRLs)) from the FDA for the same new drug application ((NDA)). Verrica was formed in 2013 and went public in 2018, raising net proceeds of $78.4 million at $15 per share. Its stock trades just over $3.50 a share, translating to a market cap of $130 million.
Pipeline
VP-102. The cause of all the consternation for Verrica shareholders – at least those holding its stock after the close of the market on May 24, 2022 – is VP-102. It is a formulation of cantharidin, which is an odorless, colorless fatty substance secreted by male blister beetles that has been employed topically to remove warts and tattoos. In higher concentrations it is extremely flammable, and if ingested at doses as small as 10mg is potentially fatal. As an aside, it is the active ingredient in the aphrodisiac Spanish fly. The company has developed cantharidin into a 0.7% drug solution administered through its single-use precision applicator that is being evaluated in the treatment of molluscum contagiosum (molluscum), as well as both common and external genital warts. Neither of the first two indications has an FDA-approved therapy, with curettage, cryotherapy, laser surgery, natural remedies, off-label drugs, and compounded unstandardized cantharidin currently employed.
To describe VP-102’s journey through the FDA approval process as a long, drawn-out affair would be an understatement. The odyssey began in 2019, after the compound in two Phase 3 trials (CAMP-1 and CAMP-2) demonstrated efficacy in the treatment of molluscum, a highly contagious and physically unattractive skin disease characterized by multiple raised flesh-colored papules that are manifestations of a pox virus – not too different from the current outbreak of monkey pox. If left untreated, the disorder can take more than two years to resolve. Verrica estimates the U.S. prevalence of molluscum at six million, with the greatest incidence in children under 14 years of age. Management places the total addressable domestic market at over $1 billion.
Returning to the approval process, after the two trials totaling over 500 patients demonstrated complete clearance of disease at day 84 in half the VP-102 population versus 16% on placebo (p<0.0001), Verrica submitted an NDA for its candidate in the treatment of molluscum and received a PDUFA date of July 13, 2020. However, the company received a CRL in July 2020 citing potential manufacturing issues as well as concerns that its device could be inadvertently misused (known as human factors). Verrica thought it had addressed these issues and resubmitted the NDA and received a PDUFA date in June 2021, which was later extended to September 23, 2021. However, another CRL was issued citing general quality deficiencies at its contract manufacturer (Sterling Pharmaceutical Services) after an FDA inspection. With the inspection classified as Voluntary Action Indicated ((VAI)) – meaning objectionable conditions or practices found at the facility but no administrative or regulatory action taken – and nothing specific to VP-102, management presumed the issue resolved and again resubmitted its application and received a May 24, 2022 PDUFA date. But again, the FDA issued a CRL, owing to the fact it placed Sterling on Official Action Indicated ((OAI)) status – the most severe violation meaning no new drug manufacturing – after another inspection of its plant.
The latest CRL and management’s surprised response regarding its issuance had some calling into question its competency. Either way, the flummoxed brass held a Type A meeting with the FDA on June 27, 2022 to discuss a path forward. As a potential solution, Verrica is engaging another contract manufacturer to provide VP-102 in the event that Sterling can’t satisfy all the deficiencies related to its OAI status. An NDA re-re-resubmission is now anticipated in 1Q23. If approved, it will be marketed under the trade name YCANTH and will essentially shut out the manufacturers of the "unapproved" compounded cantharidin.
These delays have had a significant impact on: Verrica’s stock price, which plunged 64% in the trading session after its most recent CRL; its balance sheet, which will be discussed in more detail below; and its operations, as the approval delays retard its ability to advance other clinical programs.
For example, VP-102 is also being evaluated as a therapy for both external genital and common warts. External genital warts (EGW) are caused by the human papilloma virus (HPV) and comprise ~17% of the 4.1 million annual doctor office visits for warts. Although there are FDA-approved remedies including HPV vaccines, immune response modifier imiquimod, cell mitosis inhibitor podofilox, and botanical green tea drug product sinecatechins, owing to EGW’s similarity to molluscum, Verrica believes that VP-102 can be a safe and effective treatment. After a Phase 2 study demonstrated statistical significance (with 35.1% of patients showing complete clearance of warts at day 84 versus 2.4% on vehicle (p<0.0001)) the company was set to initiate a Phase 3 trial in 2H22 with first patient expected to be dosed in 1H23. However, due to the setbacks related to the molluscum indication, the trial’s starting date has been pushed back to 1H24 as Verrica conserves capital.
Like EGW, common warts are caused by HPV. Management believes the total U.S. incidence is 22 million with only 1.5 million diagnosed annually. With no FDA-approved therapies and similarities to molluscum, the company embarked on a clinical program for VP-102 in the treatment of common warts with a two-cohort, 56-patient Phase 2 trial demonstrating clinically meaningful efficacy with 51.4% in Cohort 2 achieving complete clearance at day 84. However, when Verrica met with the FDA to lay out its Phase 3 trial protocol, the feedback suggested a second Phase 2 study would be necessary before advancing to a pivotal trial. With the molluscum-related issues putting the company in a bind, it is likely that this program is suspended until financial conditions improve.
LTX-315. The temporary de-prioritization of this program is related to the company’s other clinical asset, LTX-315. It is an oncolytic peptide designed to induce immunogenic cell death after direct injection into a tumor. In-licensed from Lytic Biopharma in 2020, it is being assessed in a Phase 2 trial for the treatment of basal cell carcinoma with the first patient injected in April 2022. As part of its deal with Lytic, Verrica is potentially obligated to pay as much as $110 million in milestones, as well as royalties in the low double digits to mid-teens. The indication is potentially significant with ~5.4 million diagnoses of non-melanoma skin cancers such as basal and squamous cell carcinomas in the U.S. annually.
VP-103. Verrica was also determining when to enter the clinic with VP-103, a second cantharidin-based compound for the treatment of plantar warts, which comprise nearly one-third of all doctor visits for warts in the U.S. That timeline is currently under reevaluation.
Out-licensing Agreement
Between VP-102’s first and second CRLs, Verrica was able to ink a development and commercial deal with Torii Pharmaceutical Co. (TRXPF) for Japan. Under the terms of the agreement, Verrica has received $12 million to date with eligibility for an additional $58 million in milestones, in addition to tiered transfer price payments for supply of product equaling mid-30s to mid-40s percentage of net sales.
Balance Sheet & Analyst Commentary:
When VP-102’s approval appeared a slam dunk in 2020, Verrica was able to line up financing totaling $50 million, of which it tapped $40 million. However, the loan was predicated on the company achieving a minimum sales thresholds for VP-102. Owing to the CRLs, Verrica was compelled to renegotiate the financing terms and move the $40 million outstanding into the restricted cash line on its balance sheet, creating a liquidity crunch. With only enough unrestricted cash to get the company into 3Q22, it was forced to execute a highly dilutive secondary offering, raising net proceeds of $26.8 million at $2.10 a share on June 29, 2022. The company had approximately $55 million of cash and marketable securities on hand prior to the capital raise.